Back to resultsIdentifying Targets of Maladaptive Metabolic Responses in Heart Failure
Primary Purpose
Heart Failure
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collection of discarded heart tissue
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Subjects are capable of giving informed consent.
- Age 19-89
- Diagnosis of chronic heart failure
Any patients scheduled for at least one of the following procedures:
- LVAD implantation or as recipient for cardiac transplantation.
- LVAD placement both as bridge to transplant and as destination therapy.
- LVAD explantation
- Valve replacement or repair
- Catheterization and myocardial biopsy for idiopathic cardiomyopathy
- Coronary artery bypass graft (CABG)
Exclusion Criteria:
- Life expectancy less than 2 weeks
- Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine >2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).
Control Myocardial Tissue from Donor Hearts Inclusion Criteria
- Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
- Normal cardiac function from medical records
Exclusion Criteria:
- Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
- Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.
Sites / Locations
- Translational Research Institute for Metabolism and Diabetes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiac surgery
Arm Description
Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
Outcomes
Primary Outcome Measures
Analyses of collected tissues
Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.
Secondary Outcome Measures
Full Information
NCT ID
NCT03032627
First Posted
January 17, 2017
Last Updated
July 21, 2023
Sponsor
AdventHealth Translational Research Institute
Collaborators
Florida Hospital Cardiovascular Institute, Sanford-Burnham Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03032627
Brief Title
Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Official Title
Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth Translational Research Institute
Collaborators
Florida Hospital Cardiovascular Institute, Sanford-Burnham Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac surgery
Arm Type
Other
Arm Description
Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
Intervention Type
Procedure
Intervention Name(s)
Collection of discarded heart tissue
Intervention Description
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
Primary Outcome Measure Information:
Title
Analyses of collected tissues
Description
Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.
Time Frame
Restricted to the time around surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects are capable of giving informed consent.
Age 19-89
Diagnosis of chronic heart failure
Any patients scheduled for at least one of the following procedures:
LVAD implantation or as recipient for cardiac transplantation.
LVAD placement both as bridge to transplant and as destination therapy.
LVAD explantation
Valve replacement or repair
Catheterization and myocardial biopsy for idiopathic cardiomyopathy
Coronary artery bypass graft (CABG)
Exclusion Criteria:
Life expectancy less than 2 weeks
Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine >2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).
Control Myocardial Tissue from Donor Hearts Inclusion Criteria
Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
Normal cardiac function from medical records
Exclusion Criteria:
Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Pratley, MD
Organizational Affiliation
Translational Research Institute for Metabolism and Diabetes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Research Institute for Metabolism and Diabetes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
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